None listed
Conditions
Brief summary
A pilot study: As part of our standard care, in line with a comprehensive blood management approach, patients presenting for primary hip arthroplasty are offered intra-operative cell salvage. One type of cell saver used is the SANGVIA system. Blood is collected during surgery, filtered and can be reinfused post-operatively. This is a relatively new technology and there is some controversy around the efficacy, safety and potential adverse effects of the reinfusion. This includes some concern whether a coagulopathy might be induced by reinfusion through various mechamisms. of cytokines. A "point of care device" "ROTEM" is well established in clinical medicine. It is comprehensive diagnostic system coagulation management. We would like to assess the patients' clotting profile before incision and the potential impact of reinfusion of the salvaged blood at the end of the operation. This will be conducted with ROTEM , testing for ex-TEM S (screening extrinsic clotting pathway & platelet contribution to clot formation), in-TEM S (screening intrinsic clotting pathway & platelet contribution to clot formation)compared to standard Lab testing (INR, aPTT). A small sample volume of the shed blood is collected and analyed for haemoglobin and platelets to assess the quality and composition of the blood. In addition a 2nd sample is frozen which will be analyzed after completion of the study to assess the presence and levels of imflammatory mediators.
Interventions
to evaluate if the reinfusion of cellsalvaged whole blood will impact on coagulation observed in standard laboratory testing and/or thrombelasometry. A minimum of 300ml blood is collected during hip replacement surgery using the SANGVIA cell saver system, filtered and then reinfused immediately post-operatively
Sponsors
Astra Tech AB
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
primary hip replacement
Exclusion criteria
contraindication to reinfusion of shed blood, pateint refusal, pre-existing coagulopathy
Outcome results
None listed